Omeprazole Magnesium (4 brand names, 3 dosage forms, 1 route)
Available dosage forms: CAPSULE, DELAYED RELEASE, TABLET, DELAYED RELEASE, FOR SUSPENSION, DELAYED RELEASE.
Routes of administration: ORAL.
Brand Names
- OMEPRAZOLE MAGNESIUM
- PRILOSEC
- PRILOSEC OTC
- TALICIA
Adverse Reactions
The following serious adverse reactions are described below and elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3)] Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.4)] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.6)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8)] Rash in Patients with Mononucleosis [see Warnings and Precautions (5.9)] Uveitis [see Warnings and Precautions (5.10)]
Mechanism of Action
TALICIA is a combination of antibacterial drugs (rifabutin, amoxicillin) and a proton pump inhibitor (omeprazole as omeprazole magnesium), an antisecretory drug [see Microbiology (12.4)].
Overdosage
TALICIA No information is available on accidental overdosage of TALICIA in humans. In case of an overdose, patients should contact a physician, poison control center, or emergency room. The available overdosage information for each of the individual components in TALICIA (omeprazole, amoxicillin and rifabutin) are summarized below: Omeprazole There have been reports of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience [see Adverse Reactions (6.3)]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. Amoxicillin In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage. In case of overdosage, adequate intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood concentrations may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin can be removed from circulation by hemodialysis. Rifabutin No information is available on accidental overdosage of rifabutin in humans. W